Custom fitted orthotic device

ABSTRACT

An orthotic device is provided, including an orthosis body adapted to be wrapped around the torso of a wearer of the device, the orthosis body having at least two segments in juxtaposed relationship. Means are provided at free end portions of the at least two segments to releasably secure the free end portions to one another. At least two cables are provided, each cable operatively connected to the at least two segments. At least two sets of pulleys are mounted on the at least two segments with each cable operatively connected to the at least two segments running through a pulley on each of the at least two segments in alteration, shortening of each cable pulling the at least two segments together and tightening the orthotic device with the aid of a mechanical advantage dependent upon the number of pulleys mounted on each of the at least two segments.

TECHNICAL FIELD

[0001] The invention relates to body braces and other orthotic devicesused in the treatment of spinal disorders and/or used subsequent tosurgery where flexing of the torso is to be minimized. Moreparticularly, the invention relates to back brace apparatus and orthoticdevices for partial or substantial immobilization of portions of thetorso, the devices having multiple modes of adjustment facilitating bothrapid donning and doffing and individualized adjustment to fit the userof the device.

BACKGROUND ART

[0002] A common method of alleviating pain in people suffering from backinjuries and promoting healing in post-operative back surgery patientsis to stabilize the spine by means of an orthosis, such as a brace. Suchbraces include a multitude of materials and designs which can be snuglyfitted around the patient's trunk. The back portion of such orthosis mayalso be provided with pockets into which are inserted lordotic pads fortreating spinal lordosis.

[0003] Such braces are effective in achieving spinal stability if wornproperly and consistently; however, most patients have difficulty inmanually adjusting the brace to fit tightly enough to provide adequatesupport. This is especially true in the case of post-operative patientswho are generally in pain and frequently lack sufficient strength tomake the necessary adjustments. This is also true when the devices covera large portion of the torso or when materials used in the constructionof the orthoses are rigid. For many patients suffering spinal ailments,these braces are also difficult to don, appropriately position andfasten and subsequently remove. This is also particularly true when thedevices are large or cumbersome or when they are constructed from rigidmaterials. In addition, because of the structures of many of thesedevices and/or the choice of materials used in their construction, theorthoses are quite uncomfortable, in many instances inducing extensiveperspiring and/or chafing. Without being consistently worn and properlyadjusted, such patient non-compliance obviously reduces theeffectiveness of the brace.

[0004] Another frequently encountered problem with these types of bracesis their inability to conform to the torso as the patient moves from astanding to a sitting position or vice versa. Thus, although such adevice may have been properly adjusted initially, the patient isrequired to make any necessary adjustments manually to vary the tension,depending on whether the patient is standing or sitting. Similarsituations and corresponding adjustments may be required as, or shortlyafter, a meal is consumed or digested. In addition, it is oftendifficult to adjust the brace to have exactly the same amount of tensionthat a patient previously found acceptable or even to set a particulartension for a particular patient.

[0005] Advances have been made in recent years to provide orthoticdevices which can be more easily adjusted to the individual patient andreadjusted when their physical position changes. Thus, in U.S. Pat. No.Re 35,940 an electromechanical back brace apparatus is described whichis provided with an electromechanical mechanism for tightening the bracearound the trunk of the patient to a desired tension. A cable and pulleyarrangement is tightened by a small motor to provide the desired tensionin the brace. A microprocessor is also provided to control the motor toobtain desired repeatable tension settings. While such a devicefacilitates rapid and repeatable adjustment of such a brace, theinclusion of an electromechanical mechanism and a microprocessorincreases the cost of such a device to a patient or to their medicalinsurance program. In addition, there is the need to periodicallyreplace batteries to power the electrically operated components.

[0006] In some situations larger orthotic devices are necessary eitherbecause the portion of the torso being supported constitutes a largevolume or because the user of the device is large. In such situations, asingle means for tensioning the device over a large area proves somewhatineffective since the dimensions of the portion of the torso beingsupported or in which there is contact with the device varysignificantly. That is, a single means of adjustment may not provide thenecessary conformity to the physical profile of the patient or mayprovide too little tension or support to achieve the orthotic objectiveswith respect to a specific portion of the torso while impartingexcessive tension or pressure to other parts of the torso.

[0007] Accordingly, it is an object of the present invention to provideorthotic devices which result in greater patient compliance since thekey to successful orthotic treatment is patient compliance. Theattributes of an effective orthotic device which induces patientcompliance includes ease of donning an doffing the device, ease ofadjusting the device, comfort to the wearer of the device, and effectiveheat dissipation. More specifically, it is a primary object of thisinvention to provide orthoses which may be tightened around the torso ofa patient to provide the necessary support with the minimal physicaleffort required on the part of the patient.

[0008] It is another object of the invention to provide orthoses whichare easily donned and doffed. It is a further object of the presentinvention to include individual controls for adjustment and customfitting of different parts of the orthotic device. It is an additionalobject to provide substantially the same pressure to all portions of thetorso supported by the orthosis.

[0009] It is another object of the present invention to provide multiplemodes of adjustment to achieve individualized adjustment of variousportions of orthosis. It is still another object of the presentinvention to provide multiple and independent means of adjustment ofvarious portions of an orthotic device. It is yet another object of thepresent invention to provide a rigid back brace apparatus having asignificant mechanical advantage that may be individually adjusted to adesired tension and conformity to an individual patient's dimensions.

[0010] It is yet another object of the present invention to provide athoracic lumbar sacral orthosis (TLSO) which is provided with multiplemeans of adjustment for individually fitting to a patient.

[0011] It is another object of the invention to provide an orthoticdevice which is capable of being rapidly adjusted and, whereappropriate, readjusted to an appropriate tension. It is another objectof the present invention to provide an orthotic device to be easilydisassembled to clean component parts of the device. It is also anobject of the invention to provide orthoses which are comfortable andwhich readily dissipate body heat.

DISCLOSURE OF INVENTION

[0012] The present invention is directed to braces and orthotic deviceswhich result in significantly increased patient compliance. This isattributable to orthoses that are both easily donned and doffed as wellas being easily and rapidly adjustable to accommodate changes in theposition of a wearer of the device. The orthotic devices of theinvention include multiple modes of adjustment which are independentlyadjustable to accommodate and conform to varying physical profiles of auser of the device as well as to accommodate a change in the position ofthe torso about which the devices are secured. The devices of theinvention provide greater patient comfort and adjustability and result,therefore, in greater patient compliance. Preferably, component parts ofthe devices may be easily dissembled and assembled for cleaning.

[0013] The orthotic devices of the present invention, include anorthosis or brace body adapted to be wrapped around the torso or trunkof a user, the brace body including at least two segments. Fasteners areprovided at the distal or outer ends of the segments of the brace bodyto detachably secure the ends around a user's torso. At least two cablesare operatively connected to the at least two segments. The orthoticdevices include at least two independent sets of pulleys, each setmounted on adjacent sides of opposing segments with each cable runningthrough a pulley on each adjacent segment in series and in alteration,shortening of each cable pulling the adjacent segments together andtightening the brace apparatus with the aid of mechanical advantagedependent upon the number of pulleys mounted in each set of pulleys oneach brace segment.

[0014] In one embodiment of the invention, the brace body includes atleast two segments and employs at least two independent sets of pulleysarranged vertically with one set disposed above the other(s). In anotherembodiment of the invention, at least two sets of pulleys are arrangedhorizontally with one set disposed in opposition to the other(s). Ineach of these embodiments, several separate and independent means ofadjustment are provided, preferably including separate adjusters foreach pulley set.

[0015] In the latter embodiment of the invention, the brace bodyincludes at least three brace body segments and at least two independentpulley sets with at least one set of pulleys securing a centrallydisposed brace body segment to a first lateral segment at one side ofthe central brace segment and at least one other set of pulleys joiningthe centrally disposed brace segment to a second lateral brace segmentdisposed at an opposing side of the central brace segment.

[0016] To facilitate disassembly and cleaning of the devices of theinvention, many of the component parts are preferably constructed to beeasily detached and separated from other component parts. This includeseach pulley set and its connecting cable. Thus, in a preferredembodiment, each set of pulleys comprises two modular banks of pulleyswhich are detachably secured to adjacent brace segments. A cable isprovided to connect pulleys in the opposing banks of pulleys in a set inseries and in alteration. The ends of each cable preferably may bejoined to form an endless cable or are attached to a handle which alsoachieves the effect of an endless cable. Preferably, the handle may beremoved from the body of the device when the modular banks of a pulleyset are removed.

[0017] Although useful for custom fitting the orthotic device to thephysical profile of an individual wearing the device, in mostsituations, the individualized control of adjustment and fitting oforthotic devices according to the invention is also quite effective whenthe device is intended to cover a large portion of the torso of thewearer or the wearer is tall. Thus, it has been found that attempting toprovide both the necessary support with the appropriate tension as wellas providing sufficient comfort to the wearer of a brace or otherorthotic device frequently falls short when a single means of control isprovided to adjust the tension of the device to suitably support andcomfortably fit the affected portion of the torso, particularly when theextent of support extends over a large region of the torso in thelongitudinal direction of the body of the user wearing the device orwhen the orthosis is constructed of rigid materials. Providing aplurality of separate adjustment devices, as in the invention,preferably at least two separate means of adjustment, allows forindividualized fitting for appropriate support and comfort over thesurface area covered by the device.

[0018] To improve appropriate support when used as a back brace, such asin a body jacket, an embodiment of the present invention includes amodular lordotic pad system. The system includes one or more flexibleand compressible pads having a size and contour appropriate to thedimensions of the wearer of the device, preferably located in theportion of the brace corresponding to the lumbar region of the back.

BRIEF DESCRIPTION OF DRAWINGS

[0019] Other objects, features and advantages will become evident inlight of the following detailed description, considered in conjunctionwith the referenced drawings of preferred embodiments according to thepresent invention. It should be understood that these drawings areexemplary only and should not be construed as limiting the invention inany way.

[0020]FIG. 1 shows a plan view of an outer side of a first embodiment ofan orthotic device according to the present invention;

[0021]FIG. 2 illustrates a plan view of an inner side of the embodimentshown in FIG. 1;

[0022]FIG. 3 illustrates an enlarged portion of the embodiment of thepresent invention illustrated in FIG. 1 with a bank of a set of themodular pulley system removed from its corresponding segment of theorthotic device of the present invention so as to reveal the undersideof the bank;

[0023]FIG. 4 shows a bank of a modular pulley set employed in a presentinvention with its cover removed;

[0024]FIG. 5 shows an inner portion of an orthosis according to theinvention containing lordotic pads;

[0025]FIG. 6 shows a first embodiment of the invention as it is worn bya patient;

[0026]FIG. 7 shows a plan view of the outer side of a second embodimentof an orthotic device according to the present invention;

[0027]FIG. 8 illustrates an inner side of a rear component piece whichforms part of a thoracic lumbar sacral orthosis (TLSO) used inconjunction with an embodiment of the present invention such as thatillustrated in FIG. 7;

[0028]FIG. 9 is an outer side of the rear component piece of the TLSOshown in FIG. 8;

[0029]FIG. 10 shows the outer or front side of a front component pieceof a TLSO and a sternal notch piece received by the front pieceaccording to the present invention;

[0030]FIG. 11 illustrates an inner side of a front component pieceillustrated in FIG. 10;

[0031]FIG. 12 shows a front view of the orthotic device of FIGS. 8, 9,10 and 11 as it is worn by a patient; and

[0032]FIG. 13 shows a side view of the orthotic device of FIGS. 8, 9,10, 11 and 12 as it is worn by a patient.

MODES FOR CARRYING OUT THE INVENTION

[0033] FIGS. 1-6 show a first embodiment of the present invention. FIG.1 illustrates the outer side of a body jacket type of back brace 10 inan extended position. The brace 10 includes a brace body 12 made of amaterial suitable to achieve the type of support sought in treating thecondition of the patient wearing the orthotic device. Accordingly, insome situations a softer, more pliant material is preferred where thedevice is intended to conform substantially to the body of the wearerand provide support but where rigid support is not necessary. In othersituations, where flexion is to be avoided, either a more rigid materialis selected for all or a portion of the body of the orthosis (such as inbody jackets) or the orthotic device is used in conjunction with othercomponent parts made from a more rigid material (such as in thoraciclumbar sacral orthoses). Suitable materials include canvass, nylon,polyethylene, nylon mesh or other similar materials. Where a more rigidorthotic device is sought, rigid polyethylene may be used alone andvarious combinations of materials may be employed to obtain propertiesof rigidity and breathability.

[0034] It may be noted that the term “rigid”, as used herein to describematerials from which the orthoses of the invention are constructed, doesnot mean totally inflexible or unyielding, since many of materialsemployed can be bent when a sufficient force is applied to a surface ofthe material. These materials typically resume their originalconfigurations when the deforming force is removed, however. As used indescribing the materials from which the invention is constructed,rigidity refers to a resistance to deformation exhibited when in use,orthoses constructed of such materials are not bent or deformed whensomeone wearing the device bends in a fore or aft direction or in alateral direction using a force to move in such direction which isconsidered not to be excessive for that person.

[0035] In a preferred embodiment of the brace body 12 illustrated inFIGS. 1, 2 and 6, two brace body segments, 12 a and 12 b, are shown,each including part of the individual adjuster or tightening means ofthe orthotic device. On opposite overlapping sides of opposite distal orfree ends 14 a and 14 b of each brace body segment are providedcomplementary fastener or fastening means for securing the two free ends14 a and 14 b together after the brace is wrapped around the patient'storso. Although, buttons and button holes, snap fasteners or othersimilar fasteners commonly used in garments may be employed to securethe free ends of the brace body 12 together, much preferred arecomplementary sections of hook-and-loop fastener fabric mounted onopposite overlapping sides of opposite body brace segments 12 a and 12 bat at least the free ends thereof. In a preferred embodiment illustratedin FIGS. 1 and 2, complementary portions of hook-and-loop fabric arerepresented by numeral 16 b and 16 c. In addition to such material beingcapable of withstanding a large amount of shear stress so that the brace10 may be kept under tension, the portions of the brace body 12 securedto one another may be easily peeled away when the apparatus is to betaken off. Furthermore, such material allows the free ends 14 a and 14 bto be removably attached to one another in a variety of positions andwith the possibility of incremental adjustment, attributes not typicallyfound in fastening systems frequently encountered in garments. Inaddition to providing such complementary portions of hook-and-loopmaterial at the free ends 14 a and 14 b of the brace body segments 12 aand 12 b, respectively, horizontal strips 16 a of hook-and-loop arearranged on the exterior surface of each brace body segment to allow forremovably securing handles attached to the ends of the cable 28 used inthe individual tension adjusters.

[0036] The preferred tension adjusters used to custom fit the orthoticdevices of the present invention to the profile of the individual wearerof these orthotic devices are shown in preferred embodiments illustratedin FIG. 14. Thus, the preferred means of individual adjustment andcustom fitting of the orthotic devices of the invention include at leasttwo independent pulley sets 20. Each set of pulleys includes a pair ofopposing banks of pulleys (an upper set including banks 22 a and 22 band a lower set including banks 24 a and 24 b). Each bank includes aplurality of individual pulleys 26 (illustrated in FIG. 4) and a cable28 is looped serially and in alteration around the pulleys 26 and isfixed at each end of the cable to a controlling device such as a handle,designated as 30 (for the upper set of pulleys that includes pulleybanks 22 a and 22 b) and 32 (for the lower set of pulleys that includespulley banks 24 a and 24 b), so as, in effect to form an endless cable.Although a cable which is anchored at one end, wound around each of thepulleys in a series could be used to achieve a suitable mechanicaladvantage and adjustment to accomplish the same degree of adjustment ofthe endless cable of a preferred embodiment of the invention, the cablewould need to be pulled to twice the length. This is not ergonomicallydesirable, nor even feasible, for the great majority of patients.

[0037] The number of pulleys provided in each bank of pulleys isdetermined by such factors as the amount of space provided for pulleyswithin each bank and the mechanical advantage being sought. The size ofthe particular bank of pulleys is determined in part by the size of theorthotic device and manufacturing considerations. Larger devices allowfor concomitantly larger pulley sets and their respective banks ofpulleys. The appropriate mechanical advantage is determined with aconsideration of the strength of the user or the type of ailmentnecessitating the use of the orthotic device, the rigidity of theorthosis being adjusted, the volume of the torso covered by the device,portion thereof being adjusted. Generally, each pulley system used inthe orthoses of the invention is constructed with an appropriate numberof pulleys to provide a minimum of effort to achieve abdominalcompression but not high enough to cause injury by over-tensioning theorthosis. Typically, this equates to a mechanical advantage for eachpulley system in the range of about 4:1 to about 30:1. For those deviceswhich require less effort to tighten, such as smaller orthoses and thoseformed from compliant materials such as those used only to treat thelumbar region of a patient, a mechanical advantage of about 4:1 to about8:1 is preferred. For orthoses which are larger or are constructed atleast in part from rigid material, such as body jackets, a mechanicaladvantage of about 6:1 to about 18:1 is preferred. In orthotic deviceswhich are very large or are substantially rigid because of the rigidnature of the materials from which they are constructed or the number ofrigid component parts, such as thoracic lumbar sacral orthoses, amechanical advantage of about 12:1 to about 30:1 is preferred.

[0038] As illustrated in FIGS. 1, 3 and 6, the ends of each cable 28 arepreferably attached to a controlling or handle device for each set ofpulleys. The device may include an easily graspable member, such as acloth tab, loop, ring or bail. In the preferred embodiments illustratedin FIGS. 1, 3 and 6, a bail shaped member 34, formed from metal orpreferably plastic, either rigid or flexible, is secured or formed aspart of a tab member 36. Preferably, the handle also includes a means ofdetachably securing the handle 30 or 32 to a body brace segment afteradjustment has been made or the device has been removed from the wearer.Such means of securing could include a series of clasps or a buckle andstrap arrangement. However, most preferred is a hook-and-looparrangement. In such a system, a piece of hook-and-loop fabric 38 isaffixed to the underside of a portion of the handle such as member 36.After adjustment has been made and the appropriate tension has beenestablished in the cable 28, the handle may be releasably secured to abrace body segment 12 a or 12 b by placing the hook-and-loop fabricportion 38 attached to the handle member 36 in contact with a portion ofthe complementary hook-and-loop material 16 a on the body brace segment12 a or 12 b, as, illustrated in FIG. 1. When a portion of hook-and-loopmaterial is used as ;a securing means on the handle it is preferred touse a thin moderately flexible plastic, such as polyethylene, to formthe handle can be pulled to and conform to the side of the patient.

[0039] Each bank of pulleys 22 a, 22 b, 24 and 24 b of the pulley sets20 is secured to a portion of a body brace segment 12 a and 12 badjacent a juxtaposed body brace segment edge thereof (14 c or 14 d).The proximate or juxtaposed edges 14 c and 14 d of the adjacent bodybrace segments 12 a and 12 b may be joined together by a portion offlexible pliant material which secures the juxtaposed edges 14 c and 14c at opposite edges of the portion of pliant material or the brace body12 may be formed as a single unitary object including brace bodysegments 12 a, 12 b and an intermediate section lying there between.Preferably, however, brace body segments 12 a and 12 b of the brace body12 are separate, detached segments joined to one another solely by cable28. This allows for greater heat dissipation by a wearer and facilitatesdisassembly and cleaning.

[0040] Although the individual pulleys may be secured directly to thematerial from which the brace body 12 is formed, it is much preferredthat they are secured to a plate, such as plate 40 illustrated in FIGS.3 and 4. The plate 40 may be affixed to the material from which the bodybrace segments are formed by any convenient fastening means, such asrivets, staples, etc. However, it is preferred that each bank of pulleysis formed as a modular unit attached to the other bank of pulleys in thepulley set on the opposing juxtaposed edge (14 c or 14 d) of theopposing brace body segment by means of one of the cables 28. As amodular unit, the plate 40 is detachably secured to a brace body segment12 a or 12 b by any convenient detachable fastening means, such ascomplementary tabs and slots, hook-and-loop fabric, etc. Preferably,however, mushroom shaped rivets or pins 42 having an exposed flangedportion are placed near the edge portions 14 c and 14 d of each bracebody segment. Plates 40 of each pulley bank 22 a, 22 b, 24 a, and 24 b,are provided with commensurately shaped and spaced key hole-shaped slots44 which detachably engage mushroom-shaped pins 42. The dimensions ofthe narrow portions of each of the key hole-shaped slots 44 are suchthat the plates 40 of each of the modular banks of pulleys may bedetachably mounted or dismounted on the pins 42 by applying a suitableamount of hand pressure. To provide additional reinforcement, the pinsmay be affixed to a separate flap 46 secured to the main brace bodysegment 12 a or 12 b. Preferably flap 46 is made from a material havinghigh tensile strength which resists tearing and the pins 42 being pulledfrom the flap. Preferably, the flap 46 has a rigidity equal to orgreater than the main portion of the body brace segments 12 a and 12 b.

[0041] Although each of the pulleys in a bank may be of the same sizeand spaced from the next adjacent pulley, a greater force is achieved.Accordingly, in situations where the nature of the anatomy varies in thearea over which the pulley set extends, an embodiment such as thatillustrated in FIG. 4 may be preferred. Thus, pulleys with largerdiameter spools and/or larger center-to-center distances between spoolsmay be placed at one end of the pulley bank and the band may be orientedsuch that the portion of the bank in which smaller pulley spools arelocated and/or where the center-to-center distance between spools issmaller is proximate to or superposed on the region of the anatomy wherethe greatest resistance to compression exists.

[0042] By forming the pulley sets 20 as modular units which may bedetachably secured to the brace body segments 12 a and 12 b or flaps 46,allows facile removal of the component parts of the orthotic device forcleaning. In addition, in the arrangement of the orthosis shown in FIG.1, the pulley sets are so arranged that pulley bank 22 b is arrangedabove pulley bank 24 b with handles 30 and 32 arranged to extend to thesame side of the orthosis and the same brace body segment 12 b. This isa typical arrangement for most wearers of body braces (as shown in FIG.6) since most individuals exhibit greater strength in their dominantarm. However, based on individual preference or where comparablestrength exists in each arm, some users may prefer an arrangement inwhich each arm controls one of the cables attached to one of the handles30 or 32, to allow individual adjustment of each pulley set 20. This maybe easily accomplished with a preferred embodiment of the invention inwhich modular pulley sets are employed since the individual pulley banksmay be detached from their corresponding pins and the pulley set rotated180° in the plane of the extended orthosis to allow reattachment of thepulley set 20 such that the handle 30 or 32 of the pulley set beingrepositioned is arranged to extend over the opposite brace body segment.

[0043] Each pulley bank 22 a, 22 b, 24 a and 24 b includes a cover 48removably attached to the base plate 40 by any convenient fastenermeans, such as screws, bolts, recesses and engaging tabs, etc.

[0044] To apply appropriate support and pressure to portions of thespine, as required by the patient's condition, a preferred embodiment ofthe invention includes appropriately configured lordotic pads 52,provided to adjust for lordosis, for the lower curve of the back. Thesepads are positioned on the interior of the orthotic device 10 adjacentthe abutting edges 14 c and 14 d. Although such pads may be permanentlyretained in the device by sewing in place and/or by covering with asuitable material, it is preferred that they be removably retained inthe brace by transverse elastic straps 50 disposed at positions on bracesegments 12 a and 12 b which allow the straps to transversely contactand hold each pad at approximately the ends and mid points of eachorthotic pad. Preferably, each pad is formed from a high densitycompressible, elastic foam material.

[0045] Although in many applications it may be unnecessary to provide alining on the interior surface of the brace body 12, to achieveadditional comfort, a liner is preferred, and most preferred is one madeof compressed foam. Preferably the liner is easily cleaned and mostpreferably is removable for cleaning. A particularly preferred liner isdesignated by numeral 54 and is a perforated foam containing a “waffle”pattern in which the pattern is defined by interconnecting channels ortroughs that intersect at the apertures to provide air circulation nextto the body. A nylon mesh may be used over the foam liner 54 to provideincreased rigidity as well as breathability.

[0046] In using this embodiment of the invention, the wearer merelyplaces the device 10 around the waist with the portion of the body brace10 having the pulley sets 20 arranged on the exterior surface and to therear of the user. The free ends 14 a and 14 b are arranged one over theother in appropriate engagement. In the preferred embodiment, thisinvolves engaging the appropriate hook-and-loop portions in facingrelationship. Once the orthotic device is secured around the torso, thewearer may then separately pull each of the handles 30 and 32 to adjustthe tension of the device to provide the degree of comfort andconformity of the brace provided by the separate adjustments of thepulley system. After adjustment, the wearer merely presses the side ofthe handle with the hook-and-loop material thereon against thecomplementary hook-and-loop strip 16 a on the brace body 12. When theuser changes body positions, tension of the individual pulley systemsand of the overall brace may be subsequently readjusted.

[0047] Although the orthotic devices of the present invention permitcustom fitting and adjusting over a wide range of dimensional variables,it is preferred to provide the present invention in a range of sizes topermit an orthotist to tailor individualized fitting of the devices to awide range of individuals within different size and profile ranges. In apreferred embodiment of the invention, an edge or bias binding 54 isprovided to prevent the materials from which the brace body 12 is formedfrom fraying or, where several layers, such as a nylon mesh and/or rigidouter layer and/or a foam cushioning liner are provided, from separatingof the adhered or laminated layers. In another preferred embodiment ofthe invention, the orthoses do not include a bias binding, therebypermitting the orthotist to cut the brace body in order to custom fitthe device to the user.

[0048] Another embodiment of the invention is shown in FIG. 7. Althoughsimilar to the first embodiment in a number of respects, including theprovision of a plurality of adjustment means, particularly preferredbeing a plurality of pulley sets, the arrangement of the pulley sets andthe number of segments of the brace body differ from the firstembodiment. In this embodiment, the same reference numerals are used torepresent the same or similar elements as represented in the embodimentsillustrated in FIGS. 1-6. FIG. 7 shows a plan view of the exterior orouter side of a second embodiment of the back brace apparatus in anextended position. The brace 110 includes a brace body 112 made of thesame or similar materials discussed above with respect to the firstembodiment of the invention illustrated in FIGS. 1-6. In the embodimentof the invention illustrated in FIG. 7, although two pulley sets 120Land 120R are employed, rather than being arranged vertically, one abovethe other, as in the embodiment illustrated in FIGS. 1-3, thisembodiment includes an arrangement where the pulley sets are disposedhorizontally and laterally. In contrast to the first embodiment in whichthe pulley sets 20 are arranged vertically and tension originates at therear portion of the brace by individually tightening the posteriorlyarranged pulley sets, the second embodiment of the invention includespulley sets 120L and 120R which are arranged laterally and which aredisposed at the sides of the device when the orthotic device 110 isplaced on the torso of the user. In addition, in contrast to the minimumof two brace body segments 12 a and 12 b of the brace body 12illustrated in FIGS. 1 to 3, the brace body 112 of the secondembodiment, illustrated in FIG. 7, includes a minimum of 3 brace bodysegments: a central brace body segment 112 c, intended to be placedsurrounding the rear and the sides of the wearer and two distal or freeend brace body segments 112 a and 112 b, arranged in symmetrical andjuxtaposed relationship to central brace body segment 112 c and intendedto be placed surrounding the sides and anterior portion of the torso.Each of the brace body segments 112 a, 112 b and 112 c may be joined byflexible, pliant material, formed as a unitary structure from the samepiece of material or may be formed as separate component parts, such asthe options existing for the first embodiment of the invention.Preferably, brace body segments 112 a, 112 b and 112 c are formed asseparate segments for reasons similar to those mentioned above for thefirst segment. The posterior segment 112 c may be formed as a singleunit or, as illustrated in FIG. 7, preferably as two units joined atopposing edges 114 f and 114 g. This reduces weight and permits betterheat dissipation.

[0049] The pulley sets 120L and 120R each consist of two pulley bankswhich provide a means of adjusting the tension and distance between theposterior brace body segment 112 c and in each set one of the two freeend segments 112 a and 112 b. Thus, pulley 120L includes pulley bank 122a, attached to brace body segment 112 a adjacent edge 114 c and pulleybank 122 b, attached to proximate, juxtaposed brace body segment 112 cadjacent edge 114 e. A cable 28 runs serially and in alteration throughthe pulleys of each of the pulley banks 122 a and 122 b, therebyoperatively connecting each of the banks in the pulley set 120L. Theends of the cable are attached to a handle, such as handle 130 which isprovided with features similar to handle 30 of the first embodiment.Likewise, pulley set 120R includes pulley banks 122 c and 122 d, affixedto proximate, juxtaposed facing portions of brace body segments 112 cand 112 b, respectively, at juxtaposed edges 114 f and 114 d,respectively. A cable 28, operatively connects the cable banks of 122 cand 122 d of pulley set 120R serially and in alteration, the ends ofcable 28 being attached to a handle 132 similar to or the same ashandles 30 and 32 of the first embodiment or 130 of this embodiment.Since the pulley sets in this embodiment are arranged horizontally andlaterally rather than vertically, one above the other, as in the firstembodiment, it is preferred that the pulley sets 120L and 120R, andtheir concomitant handles 130 and 132, be so arranged that they arepulled from opposite sides of the body rather than the same side ofbody. However, where the condition of the user so requires, and wherethe preferred embodiment of the device includes modular pulley sets,preferred as in the first embodiment, one of the pulley sets may bedetachably removed from its respective brace body and rotated 180° inthe plane of a brace body segment so that both handles may be pulledfrom the same side of the body.

[0050] Orthotic device 110 may be provided with similar fastening orclosure means as used in the orthosis 10. Preferably, the means for bothclosure and fastening around the torso of the individual, as well asgross adjustment of the device, and preferably for securing of theindividual handles 130 and 132 is provided by hook-and-loop fabricportions. As in the first embodiment, the hook-and-loop portions usedfor fastening and gross adjustment of the device may be provided at thefree or distal ends of the brace body segments such that they are insuperposed relationship when the free ends overlap. In the embodimentshown in FIG. 7, the portions of hook-and-loop material are providednear the free edges 114 a and 114 b at appropriate positions and on theinterior and exterior surfaces of the device and also appropriatelypositioned to detachably secure handles 130 and 132. In addition, edges114 a and 114 b of brace body segments 112 a and 112 b, respectively maybe configured more closely to the shape of edges 14 a and 14 b of thefirst embodiment illustrated in FIGS. 1 and 2, particularly whenorthosis 110 is used as a stand alone device. That is, edges 114 a and114 b may be shaped in the form of projecting tabs which allow bracebody segments 112 a and 112 b to more fully overlap one another and moreeasily engage a fastening and closure means provided at the free ends ofthese segments. The configuration of the free end brace body segments112 a and 112 b shown in FIG. 7 are quite compatible, however, withanother embodiment of the invention discussed below.

[0051] As indicated above, depending upon the particular ailment ormedical condition of the patient, the orthoses of the present inventionmy be formed from either flexible materials or rigid materials. In bothof the previously discussed embodiments of the invention, when a rigidbody jacket is desirable, either portions of, or the entire device, maybe formed of a rigid plastic material, in which the rigidity of theplastic is selected based upon the amount of patient body flexure whichcan be tolerated for the ailment or prescribed treatment procedure ofthe user of the device. In many instances, all or a portion of theorthosis, particularly the rear portion of the device, is formed from arigid plastic material. This is true for rigid body jackets. In manyinstances, as a result of surgery, forward flexure of the patient is tobe minimized or substantially eliminated. In such instances, a physicianmay prescribe a thoracic lumbar sacral orthosis (TLSO), which isintended to prevent forward flexure of the upper portion of the torso.The body braces of the present invention may be used with additionalcomponent parts to form TLSOs which are both easily donned and doffedand include multiple means of adjustment which allow the devices to beindividually and separately adjusted to provide extensive posterior andanterior adjustment options, as well as assuring that certain portionsof the body brace conform to the profile and body dimensions of thewearer. Although the preferred TLSO orthosis of the invention isdiscussed herein in terms of a combination with the body brace device110, shown in FIG. 7, it should be understood that similarly constructedand arranged devices, discussed below, may also be used in conjunctionwith all of the body braces discussed herein, such as body brace 10.

[0052] The three component parts used in addition to and in conjunctionwith the previously described body brace type of orthotic devices of theinvention to form the TLSO devices of the invention include thecomponent parts illustrated in FIGS. 8 to 11. These components includesternal notch piece 260, shown in FIGS. 10, 12 and 13. The sternal notchpiece 260 includes a rigid adjustment piece 262 formed form a metal suchas steel or a rigid high tensile strength plastic. The adjustment piece262, formed as a post, is provided with adjustment apertures 264 toallow positioning of the sternal notch piece. Attached to the upperportion of the adjustment piece 262 of the sternal notch piece is a bodyconnecting piece, 266, formed as one or two segments intended to contactthe sternum region of a patient when the TLSO is worn. On the innersurface of the body contacting piece 266 is affixed compressible elasticfoam pads (not shown). The body contacting piece 266 is pivotallysecured to the post 262 by means of a hinge-like arrangement including arod or a spindle 268 disposed transverse the body contacting piece 266and formed as part of or secured at the rear thereof at both ends of therod 268, the rod being in turn secured to the adjustable post 262 bymeans of a sleeve and/or clamp 269 attached to the adjustment piece 262and which encircles the rod 268 at approximately its midpoint.

[0053] A substantially rigid breast plate or front piece 270 (shown inFIGS. 10 and 11) is used to movably secure the sternal notch piece 260to the TLSO. Front piece 270, formed from a rigid plastic material, suchas polyethylene, includes an adjustment piece receiving portion 272arranged vertically in the front piece. The adjustment piece receivingportion 272 includes a channel formed therein (not shown) commensuratein shape and length to slidably receive adjustment post 262 of thesternal notch piece 260. Placed intermediate the channel entranceway ofthe adjustment piece receiving portion 272, and the bottom of theadjustment piece receiving portion 272 is provided an aperture engagingdevice 274 intended to engage adjustment apertures 264 of the adjustmentpost 262. Preferably, the aperture engaging device 274 is amushroom-shaped spring loaded pin, the free end or tip of which may beretracted partially from the post receiving portion channel against thetension of the spring by pulling outwardly on the exposed head of thepin to disengage the tip of the pin from apertures 264. Release of thepin to a biased position permits engagement of the tip of the pin 274with a specific aperture 264. By pulling outwardly on the pin 274, thepin is released from an aperture and the adjustment post 262 may beslidably repositioned and the pin therefore released in order to biasagainst the adjustment post. If the pin does not immediately engage anaperture 264 in the post 262, the post may be raised or lowered to thenearest suitable position.

[0054] At the lateral upper portions of the body contacting piece 266are located strap engaging members 269, formed preferably as slottedtabs which are pivotally secured to the body contacting pad 266 suchthat they rotate substantially in the plane of the pads. The strapengaging members 269 are intended to engage or retain straps 282 (shownin FIGS. 8, 9, 12 and 13), which are secured to a back piece 280 bystrap retainers 284, which may be the same or similar to strap engagingmembers 269, thereby removably securing the front piece 270 to the backpiece 280. The straps or belts 282 include buckles or other adjustmentmeans (not shown) which allow for gross adjustment to fit the wearer ofthe orthotic device. The distal or free ends 286 of the straps 282 passthrough the slots of the strap retainers 269 of the body contact pieces266. The straps 282 and/or the free ends 286 of the straps includefastening means (not shown) to secure the straps 282 which havepassed-through the strap retainers 269. Suitable fasteners includingbuckles, snaps or, preferably, complementary hook-and-loop fabricfasteners, secured at appropriate positions to the straps, such thatwhen the free ends of the straps have passed through the slots of thestrap engaging members 269 and folded back on themselves, they areremovably secured thereto.

[0055] The back piece 280 may be formed from materials similar to thosefrom which the front piece is formed. Each of the front and back piecesis preferably formed from a rigid plastic material that yields tobending under sufficient pressure but which has a memory and springsback to its original shape when pressure is released. The rigidity ofthe front piece 270 and back piece 280 must be sufficiently high thatwhen the TLSO is properly placed on the patient in combination with abody brace of the invention, and the sternal notch piece 260 isappropriately adjusted, forward movement of the torso, particularly theupper part of the torso, is minimized or prevented. Plastic materialssuch as nylon and polyethylene are preferred. Portions of the frontpiece 270 or back piece 280 may also include a mesh material, such asnylon mesh to provide breathability. Both the front piece and the backpiece may include a cushioning liner at the surface of the componentpieces intended to be placed in contact with the wearer. Preferably thecushioning liners are formed from a dense, substantially non-compressivetype of foam and preferably have a foraminous waffle structure,preferably of the type discussed above. Such liners may be formed orlaminated to the inner surfaces of the front piece 270 or back piece 280or may be formed as separate removable liners which are detachablysecured to the interior surfaces of the front piece 270 and the backpiece 280 by suitable fasteners such as snaps or complementary portionsof hook-and-loop material. It is preferred that the removable feature beincorporated into the device to permit ease of cleaning.

[0056] As illustrated in FIGS. 7 and 8, the back piece 280 is providedwith two lateral wing portions 288 having a cross-sectionalconfiguration that is generally curved to broadly conform to the size ofa human torso. Each of the lateral wing portions 288 is formed from amoderately rigid plastic material, such as nylon mesh to increasebreathability, and which has a configurational memory, in that it may betemporarily bent or flexed to a substantial degree but it reverts itsoriginal configuration when forces causing such temporary deformationsare removed.

[0057] The inner surface of the back piece (as shown in FIG. 8) includeselastic retention straps 250 sewn at appropriate locations to allow forthe retention and removal of lordotic pads of the type discussed abovein connection with the first embodiment of the invention. Front piece270 and back piece 280 may be provided with detachable retaining meansand/or fasteners proximate to the lateral edges thereof such that thebody brace 110 (or 10) is retained in the appropriate position when theTLSO is assembled. Preferred are strips of hook-and-loop material 271and 281 placed on the exterior surfaces proximate to the lateral edgesof the front and back pieces 270 and 280, respectively. These strips ofhook-and-loop material engage complementary portions of hook-and-loopmaterial adhered at appropriate corresponding locations on the interiorsurface of the body brace 10 or 110.

[0058] When preferred embodiments of the invention are employed, theadjustment piece 262 of the sternal notch piece 260 is placed in thechannel of the front piece 270. The straps 282 of the rear piece 280 arethreaded through the slots of the strap retention pieces 269 andsecured, thereby joining the front piece 270 to the rear piece 280.

[0059] In using the TLSO devices of the present invention, the TLSOcomponent parts e.g., the front piece 270, sternal notch piece 260 (FIG.10) and back piece 280 (FIGS. 8 and 9), are joined and thereafter theassembled components are placed on the wearer. The components areadjusted to the wearer, as indicated above, and a body brace, preferablybody brace 110, is fitted around the torso of the wearer and secured inplace with the fastening means provided. When an embodiment of theinvention that includes a hook-and-loop fastening system is employed,the body brace 110 is merely pressed in place to secure the orthosis. Todoff the device, of a body brace end segment, lateral edge such as 114 aor 114 b, is pulled away from the front piece 270 and the donningprocess is reversed. To assist in the removal process, a preferredembodiment provides a grasping member such as D-shaped ring 118 held inplace with a strip of cloth sewn in place at lateral edges of each bodybrace end segment (e.g., 114 a and 114 b). The D-shaped rings 118 allowthe wearer to firmly grasp and pull the edges more positively.

1. An orthotic device comprising: an orthosis body adapted to be wrappedaround the torso of a wearer of the device, the orthosis body having atleast two segments in juxtaposed relationship; means provided at freeend portions of said at least two segments to releasably secure saidfree end portions to one another; at least two cables, each cableoperatively connected to said at least two segments; at least two setsof pulleys mounted on said at least two segments with each cableoperatively connected to said at least two segments running through apulley on each of said at least two segments in alteration, shorteningof each cable pulling said at least two segments together and tighteningthe orthotic device with the aid of a mechanical advantage dependentupon the number of pulleys mounted on each of said at least twosegments.
 2. An orthotic device according to claim 1 , wherein said atleast two segments comprise two segments, said at least two sets ofpulleys comprise two sets of pulleys and said at least two cablescomprising two cables.
 3. An orthotic device according to claim 2 ,wherein said two sets of pulleys are disposed vertically with respect toeach other at juxtaposed edges of said two segments.
 4. An orthoticdevice according to claim 2 , wherein each cable is operativelyassociated with a separate set of pulleys.
 5. An orthotic deviceaccording to claim 4 , wherein each set of pulleys with an associatedcable provides a mechanical advantage of about 4:1 to about 30:1.
 6. Anorthotic device according to claim 1 , wherein each set of pulleyscomprise two banks of pulleys and each bank of pulleys of a set ofpulleys is mounted on a juxtaposed edge of an adjacent segment.
 7. Anorthotic device according to claim 1 , wherein each of said at least twocables is an endless cable.
 8. An orthotic device according to claim 1 ,wherein each of said at least two cables comprise cables having two freeends secured to a handle element.
 9. An orthotic device according toclaim 6 , wherein each bank of pulleys includes a plate on which pulleysare mounted, said plate being detachably mounted on a segment of said atleast two segments.
 10. An orthotic device according to claim 1 ,wherein said detachable securing means comprise portions ofhook-and-loop fastener material disposed on overlapping portions of saidfree end portions of said at least two segments.
 11. An orthotic deviceaccording to claim 1 , wherein at least a portion of each of said atleast two segments is formed from a rigid material.
 12. An orthoticdevice according to claim 1 , wherein said at least two segmentscomprise at least three segments, said at least two sets of pulleyscomprise two sets of pulleys and said at least two cables comprise twocables.
 13. An orthotic device according to claim 12 , wherein said atleast three segments comprise at least one central segment having firstand second opposed lateral edges, at least one first lateral segmentdisposed at said first opposed lateral edge of said at least one centralsegment and at least one second lateral segment disposed at said secondopposed lateral edge.
 14. An orthotic device according to claim 13 ,wherein said two sets of pulleys are disposed horizontally with respectto each other and includes a first set of pulleys mounted on said atleast one central segment and said at least one First lateral segment,and a second set of pulleys is mounted on said at least one centralsegment and said at least one second lateral segment.
 15. An orthoticdevice according to claim 12 , wherein each cable is operativelyassociated with a separate set of pulleys.
 16. An orthotic deviceaccording to claim 15 , wherein each set of pulleys-with an associatedcable provides a mechanical advantage of about 4:1 to about 30:1.
 17. Anorthotic device according to claim 8 , wherein each handle element hasmounted thereon a portion of a hook-and-loop material complementary to aportion of a hook-and-loop material disposed on an outer surface of saidat least two segments.
 18. An orthotic device according to claim 17 ,wherein said handle element is formed from a flexible material.
 19. Anorthotic device according to claim 1 , wherein lordotic pads are mountedat inner surfaces of the orthosis body, symmetrically and atsubstantially the center of the orthosis body.
 20. An orthotic deviceaccording to claim 1 , wherein each set of pulleys comprise two banks ofpulleys, each bank of pulleys including at least one pulley having aspool diameter different in size than remaining pulleys in the set. 21.An orthotic device according to claim 13 , wherein each free edge ofsaid at least one first lateral segment and said at least one secondlateral segment has a grasping element attached thereto.
 22. A thoraciclumbar sacral orthosis comprising: a rigid front piece; a sternal notchpiece, movably and adjustably secured to said rigid front piece; a rigidrear piece, removably and adjustably secured to said rigid front piece;and a body brace comprising: a brace body adapted to be wrapped aroundthe torso of a patient, said front piece and said rear piece, said bracebody comprising at least two brace body segments; means provided at freeend portions of said at least two brace body segments for detachablysecuring the two free end portions together around the patient's torso;at least one cable operatively connected to said at least two brace bodysegments; and at least one set of pulleys mounted on each of said atleast two brace segments with the cable running through a pulley on eachsegment in alteration, shortening of the cable pulling the at least twobrace body segments together and tightening the body brace with the aidof a mechanical advantage dependent upon the number of pulleys mountedon each of said at least two brace body segments.
 23. A thoracic lumbarsacral orthosis according to claim 22 , wherein said body brace isremovably and adjustably secured to said front piece and said rearpiece.
 24. A thoracic lumbar sacral orthosis according to claim 23 ,wherein outer surfaces of said front piece and said rear piece includeportions of hook-and-loop material complementary to portions ofhook-and-loop material on at least a portion of an inner surface of saidbrace body.
 25. A thoracic lumbar sacral orthosis according to claim 22, wherein said at least two brace body segments comprise at least threesegments, said at least two sets of pulleys comprise two sets of pulleysand said at least one cable comprises two cables.
 26. A thoracic lumbarsacral orthosis according to claim 25 , wherein said at least threesegments comprises at least one central segment having first and secondopposed lateral edges, at least one first lateral segment disposed atsaid first opposed lateral edge of said at least one central segment andat least one second lateral segment disposed at said second opposedlateral edge.
 27. A thoracic lumbar sacral orthosis according to claim26 , wherein said two sets of pulleys are disposed horizontally withrespect to each other and includes a first set of pulleys mounted onsaid at least one central segment and said at least one first lateralsegment, and a second set of pulleys is mounted on said at least onecentral segment and said at least one second lateral segment.
 28. Athoracic lumbar sacral orthosis according to claim 25 , wherein eachcable is operatively associated with a separate set of pulleys.
 29. Athoracic lumbar sacral orthosis according to claim 28 , wherein each setof pulleys with an associated cable provides a mechanical advantage ofabout 4:1 to about 30:1.
 30. A thoracic lumbar sacral orthosis accordingto claim 25 , wherein each of said at least two cables comprise cableshaving two free ends secured to a handle element.
 31. A thoracic lumbarsacral orthosis according to claim 30 , wherein each handle element hasmounted thereto a portion of a hook-and-loop material complementary to aportion of a hook-and-loop material disposed on a surface of said atleast two segments.
 32. A thoracic lumbar sacral orthosis according toclaim 31 , wherein said handle element is formed from a flexiblematerial.
 33. A thoracic lumbar sacral orthosis according to claim 26 ,wherein each free edge of said at least one first opposed lateralsegment and said at least one second opposed lateral segment has agrasping element attached thereto.
 34. A thoracic lumbar sacral orthosisaccording to claim 22 , wherein said at least two brace body segmentscomprise two segments, said at least one set of pulleys comprise twosets of pulleys and said at least one cable comprises two cables.
 35. Athoracic lumbar sacral orthosis according to claim 22 , wherein saidsternal notch piece includes an adjustment piece and said front pieceincludes an adjustment piece receiving portion provided with anadjustable member for engaging said adjustment piece.